Cladaxxa 500 mg (amoxicillin + Clavulanic Acid) (Analog Clavacillin, Clavamox, Clavaseptin, Betacillin, Sinulox, Synulox), 12 tablets

Description

The tablets are pink, spotted, and round in shape with a fracture line on one side.

The tablet can be divided into halves.

Storage

1 tablet (1750 mg) contains active substances:

• amoxicillin (in the form of amoxicillin trihydrate) – 400 mg,
• clavulanic acid (in the form of diluted sodium clavulanate) – 100 mg.

Excipients: microcrystalline cellulose, magnesium stearate, silicon colloidal anhydrous, sodium starch glycolate (type A), dried autolyzed yeast, erythrosine (E127).

Pharmacological properties

ATS vet classification code QJ01 – antibacterial veterinary drugs for systemic use. QJ01CR02 – Amoxicillin and enzyme inhibitor.

Amoxicillin is a semi-synthetic aminopenicillin (ß-lactam antibiotic) with a broad spectrum of antimicrobial activity. The mechanism of action consists in disrupting the synthesis of the bacterial cell wall, which leads to the lysis of the bacterial cell, namely, when ß-lactam antibiotics freely pass through the peptidoglycan layer in gram-positive bacteria and the hydrophobic barrier in gram-negative bacteria to the cytoplasmic membrane.

Clavulanic acid inactivates the ß-lactamase of the bacterial cell and, thereby, restores the sensitivity of the bacterium to the bactericidal action of amoxicillin in concentrations that are easily reached in animal tissues after the introduction of the drug.

The combination of amoxicillin/clavulanic acid has a wide spectrum of bactericidal action against gram-positive (Staphylococcus spp., Clostridium spp., Corynebacterium spp., Peptostreptococcus spp., Streptococcus spp.) and gram-negative (Escherichia coli, Salmonella spp., Klebsiella spp., Pasteurella spp.) ) of bacteria, including ß-lactamase-producing strains of microorganisms.

The level of antimicrobial sensitivity of certain pathogenic microorganisms that cause diseases of the respiratory organs, urinary tract, and skin, determined in European studies, was as follows:

Respiratory infections (data collected in 2019)

Diseases of the urinary tract (data collected in 2017 and 2019)

Skin disease (registered in 2016)

The Clinical and Laboratory Standards Institute (CLSI) has established amoxicillin/clavulanate MICs for staphylococci and streptococci causing skin and soft tissue infections and urinary tract infections in cats and dogs (CLSI document VET01S, 5th edition, 2020) as follows: <0.25/0.12 μg/ml — the microorganism is sensitive; >1/0.5 μg/ml — resistant. The MIC of amoxicillin/clavulanate for susceptible strains of E. coli causing skin and soft tissue infections in cats and dogs is <0.25/0.12 μg/ml and for urinary tract infections <8/4 µg/ml

Amoxicillin is well absorbed after oral administration. Bioavailability in dogs is 60-70%. Amoxicillin has a relatively small volume of distribution, a low level of binding to plasma proteins (34% in dogs) and a short half-life by active tubular excretion through the kidneys. After absorption, its highest concentrations are found in the kidneys (urine) and bile, and then in the liver, lungs, heart and spleen. The distribution of amoxicillin in the cerebrospinal fluid is low unless the meninges are inflamed.

After oral administration of amoxicillin to dogs, the maximum concentration in plasma C _max  (7.31 μg/ml) is reached after approximately 1.37 hours. The average half-life of amoxicillin was 1.21 hours.

Clavulanic acid is well absorbed after oral administration. It does not penetrate well into the cerebrospinal fluid. Binding to blood plasma proteins is approximately 25%, and the half-life is short. Clavulanic acid is mainly excreted unchanged in the urine.

After oral administration of the drug to dogs, the average value of _Cmax of clavulanic acid (1.33 μg/ml) is reached in approximately 1.02 hours. The average half-life of clavulanic acid is 0.83 hours.

Application

Treatment of dogs for diseases of the skin (including treatment of deep and superficial pyoderma), soft tissues (abscesses and anal saculitis), oral cavity (for example, gingivitis), urinary tract, respiratory organs (diseases of the upper and lower respiratory tract), digestive tract (enteritis) caused by microorganisms sensitive to amoxicillin and clavulanic cyst.

Dosage

Orally at a dose of 10 mg of amoxicillin and 2.5 mg of clavulanic acid per 1 kg of body weight, i.e. 12.5 mg of combined active substances per 1 kg of body weight, twice a day (corresponding to 25 mg of combined active substances per 1 kg per day) or:

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

If the animal does not accept the tablet from the hand or bowl, then the tablets can be crushed and added to a small amount of feed, and then fed immediately.

In most cases, the course of treatment is 5-7 days. Chronic diseases may require longer treatment at the discretion of the veterinarian.

Contraindication

Hypersensitivity to penicillins and other ß-lactams, to any excipients.

Do not use the drug for horses, rabbits, ants, hamsters, chinchillas and small herbivores.

Do not use in animals with severe renal impairment accompanied by anuria and oliguria.

Do not use simultaneously with chloramphenicol, antibiotics of the group of cephalosporins, tetracyclines, macrolides.

Do not use in case of known resistance to the combination of amoxicillin/clavulanic acid.

Side effect

Very rarely, treated animals may develop hypersensitivity reactions to penicillins; in such cases, the use of the drug should be stopped and symptomatic treatment prescribed.

Very rarely, disorders of the digestive tract (diarrhea, vomiting) may occur after taking the drug. Treatment may be discontinued depending on the severity of side effects and the benefit/risk assessment by the veterinarian.

Special precautions for use

In animals with impaired liver and kidney function, the drug should be used only after a risk assessment by a veterinarian, and the dosage should be carefully considered. The use of the drug should be based on a test for the sensitivity of disease-causing microorganisms to the combination of amoxicillin/clavulanic acid.

Use of the drug outside of the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may reduce the effectiveness of treatment with other beta-lactam antibiotics due to possible cross-resistance.

Official and local policy regarding antibiotic therapy should be taken into account when using this drug. There are data on the growth of antibiotic resistance of E. coli, including polyresistance.

Do not use in case of detection of bacteria sensitive to penicillins of a narrow spectrum of action or separately to amoxicillin.

Chewable tablets are flavored. In order to prevent any accidental ingestion of tablets, it is necessary to keep them in a place inaccessible to animals.

Use during pregnancy, lactation, pregnancy

Laboratory studies in rats and mice have shown no evidence of teratogenic, fetotoxic or maternotoxic effects.

The safety of the drug has not been evaluated in pregnant and lactating females.

It is recommended to use the drug in animals during pregnancy and lactation only when the benefit of the drug outweighs the possible risks, according to the decision of a veterinary medicine doctor.

Interaction with other means or other forms of interaction

There is a possibility for allergic cross-reactivity with other penicillins.

Penicillins can increase the antibacterial activity of aminoglycosides.

Special precautions for persons and service personnel

Penicillins and cephalosporins can cause hypersensitivity (allergy) after injection, inhalation, consumption, or skin contact. Hypersensitivity to penicillins can lead to cross-reactions with cephalosporins and vice versa. Allergic reactions to these substances can be serious.

If you know about hypersensitivity to amoxicillin, you should not work with such drugs. The drug should be used with caution. If there was contact with the drug and symptoms of allergy (redness of the skin) appeared, you should consult a doctor. Itching of the face, eyes or lips, difficulty breathing are more serious symptoms and require immediate medical attention. After working with the drug, it is necessary to wash hands.

Release form

Laminated aluminum blisters of 6 tablets, in cardboard boxes of 12, 60 or 300 tablets.

Storage

Dry, dark place inaccessible to children at temperatures from 0 °C to 25 °C.

Expiration date

2 years.

The unused half of the tablet must be returned to the blister and used within 24 hours.

For use in veterinary medicine!